REFERENCE TO RELATED APPLICATIONSThis application claims the benefit of priority from Provisional Application Ser. No. 60/647,798 filed Jan. 31, 2005.
BACKGROUND OF THE INVENTION1. Field of the Invention
The present invention relates to an apparatus for delivery of intravenous medications. More particularly, the present invention is a multiple medication IV pump for automated delivery of a medication from one of several medication vials stored within the multiple medication IV pump.
2. Description of the Related Art
Intravenous (IV) delivery of fluids to a patient is commonplace in medical settings, ranging from the injection of a medication with a hypodermic syringe to the infusion of fluids, medications, and nutritional supplements by a pump.
An IV infusion pump is typically used when it is necessary to give a fluid, such as a medication or a nutritional supplement, at a controlled rate over a relatively long time period. An IV line, or catheter, is placed into one of the patient's veins, and connected by a length of tubing to the IV infusion pump, which is, in turn, connected to an IV bag containing the fluid to be supplied.
In contrast to the controlled delivery of a fluid over a relatively long period of time, some medications are administered as a bolus injection, pushing a prescribed amount of the medication into the patient at once. A bolus injection may be made by injecting the medication, with a hypodermic syringe, directly into the patient's vein or body. Preferably, a medication is injected into an IV line that is placed in one of the patient's veins. Generally, administration of a medication into an IV line is followed by a flush of saline solution to ensure that all of the medication has been pushed into the patient. It is common to place an IV line for the purpose of administering bolus injections, such as when multiple intravenous injections may be required or a medication may need to be quickly administered intravenously, so that it is undesirable to spend time to locate a suitable vein for injection.
It is sometimes necessary to deliver multiple medications, or multiple doses of a single medication, over a relatively short time period. One example is in cardiac care, such as in response to a cardiac arrest. Advanced Cardiac Life Support protocols recommend various medications during the course of treating cardiac emergencies. In certain situations, bolus administration of a medication is repeated during the course of treatment until a desired outcome is achieved. In other situations, bolus administration of multiple medications may be given in sequence. In still other situations, bolus administration of one or more doses of one or more medications may be given along with, or followed by, a slow or drip infusion of a medication.
Automated delivery of a sequence of medications would save time, and could help to reduce mistakes in an emergency situation. While an IV pump is useful in delivering a medication, such pumps are typically limited to delivering a slow infusion of a single, or a limited number of, medications. While IV pumps are known to utilize multiple medication channels, and to employ a cartridge system allowing quick exchange or replacement of a medication-containing cartridge, the ability of an IV pump to load itself with a medication automatically from a self-contained medication supply, or to select proper medications for delivery according to a predefined protocol, is largely unknown.
Thus, a multiple medication IV pump solving the aforementioned problems is desired.
SUMMARY OF THE INVENTIONThe multiple medication IV pump provides automated intravenous delivery of one or more medications. A carousel assembly within the multiple medication IV pump holds multiple medication vials, and a computerized control circuit operates the carousel to select a given medication, position the medication proximate to a spiking unit and mixing chamber, and deliver the contents of the medication vial into an IV solution stream.
The spiking unit and mixing chamber comprise a hollow chamber and a hollow spike, or needle, extending from the hollow chamber. The spike is adapted for insertion into a medication vial so that the contents of the medication vial flow into the mixing chamber. A fluid entry port located near the top of the mixing chamber is connected by a fluid conduit to a pump so that a fluid may be pumped into the mixing chamber. A fluid exit port located near the bottom of the mixing chamber is connected by a fluid conduit to a pump so that a fluid may be pumped out from the mixing chamber.
The carousel comprises a central hub, from which extends a plurality of track arms adapted to hold multiple medication vials. The carousel rotates to position a selected one of the track arms proximate to the spiking unit. Each track arm has a movable track disposed about the perimeter of the track arm, the track having a plurality of medication vial holders. As the track moves about the perimeter of the track arm, medication vials held in the medication vial holders are moved. Thus, by selecting a given track arm to be rotated into position proximate to the spiking unit, and then by rotating the track arm's track to position a medication vial holder in alignment above the spiking unit, a selected medication vial (or vial holder position) is brought into alignment with the spiking unit to allow delivery of the medication into the mixing chamber.
A vial-handling arm is associated with each track arm. Each vial-handling arm is adapted to grasp a medication vial from a vial holder of the track, and spike the medication vial onto the spiking unit. Each vial handling arm is further adapted to remove an empty vial from the spiking unit and to drop the vial for disposal.
A control circuit, including a display and keypad, allow for selection of a single medication, or a series or protocol of medications, to be automatically administered to a patient through an IV line in connection with the multiple medication IV pump.
These and other features of the present invention will become readily apparent upon further review of the following specification and drawings.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1A is a perspective view of a multiple medication IV pump according to the present invention.
FIG. 1B is a perspective view of a multiple medication IV pump according to the present invention, opened to show an interior medication vial handling mechanism.
FIG. 2 is a perspective view of a medication carousel and a spiking unit and mixing chamber of a multiple medication IV pump according to an embodiment of the present invention.
FIG. 3 is a perspective view of a pump, spiking unit, and mixing chamber assembly mounted on an inside wall of the multiple medication IV pump according to an embodiment of the present invention.
FIG. 4 is a side view of an arm assembly portion of the medication carousel shown inFIG. 2.
FIG. 5A is a top view of a medication vial track portion of the medication carousel shown inFIG. 2.
FIG. 5B is a side view of the medication vial track shown inFIG. 4.
FIG. 6A is a side view of a vial handling arm portion of the medication carousel shown inFIG. 2.
FIG. 6B is a top view of the vial handling arm shown inFIG. 6A.
FIG. 7 is a block diagram of the spiking unit and medication chamber of the multiple medication IV pump according to the present invention.
FIG. 8 is a block diagram of a control circuit for the multiple medication IV pump according to the present invention.
FIG. 9 is a block diagram of a stored medication library database for the multiple medication IV pump according to the present invention.
FIG. 10 is a flowchart describing the general operation of the multiple medication IV pump according to the present invention.
Similar reference characters denote corresponding features consistently throughout the attached drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTSThe present invention is multiple medication IV pump, designated generally as10 in the drawings. Referring toFIGS. 1A,1B, and2, the multiplemedication IV pump10 provides automated intravenous delivery of one or more bolus medications. Medication vials for multiple medications are contained within the multiplemedication IV pump10. Acontrol circuit32 allows a user to select a medication, or a series of medications, for intravenous delivery through anIV line12 to a patient. The medications are delivered along with a fluid solution, such as a normal saline solution, used to flush the medication through theIV line12, or to dilute the medication for correct administration.
The multiplemedication IV pump10 comprises anexterior housing14 having atop shell16 and abottom shell26. The top shell comprises a cylindricalouter wall18 and a top20, while thebottom shell26 comprises a cylindricalouter wall28 and a bottom30. The cylindricalouter wall18 of thetop shell16 comprises a hinged and movablefront half22 and a fixedrear half24, so that thefront half22 may be opened for access into the interior of thehousing14. In the illustrated embodiment, thetop shell16 is removable from thebottom shell26, and the top20 of thetop shell16 is hinged, the top20 being secured to thetop shell16 by ahinge21. Alock19 secures the top20 in a closed position. Adisposal chute31 is disposed in thebottom shell26 for removal of spentmedication vials40 through the bottom30 of thehousing14. A receptacle may be located below an outlet of thedisposal chute31 for collection of the spentmedication vials40.
The multiplemedication IV pump10 is supported by atelescoping pole15 mounted to thehousing14. Thetelescoping pole15 has a plurality oflegs25 attached to the lower end of thepole15.Coasters23 may be provided at the ends of the legs to prevent the support legs from marring the floor or other supporting surface. A pair ofhorizontal support arms17 is attached to the top of thetelescoping support pole15. Eachsupport arm17 is provided with a hook at the free end adapted for holding anIV bag50. Thesupport arms17 are pivotally attached to the top of thetelescoping pole15 so that they can be rotated together in the horizontal plane to form a carrying handle for lifting the multiplemedication IV pump10 during transport.
Thecontrol circuit32, comprising adisplay34 andkeypad36, is disposed on thehousing14 for operation of the multiplemedication IV pump10 by a user. In the illustrated embodiment, thedisplay34 andkeypad36 are located on a front exterior surface of thebottom shell26, although other configurations are suitable.
Within thehousing14 is acarousel assembly38, adapted to hold a plurality ofmedication vials40 or cartridges, and a spikingunit42 and mixingchamber44, adapted to receive amedication vial40 and introduce the contents of themedication vial40 into a fluid stream within theIV line12. Thecarousel assembly38, under control of thecontrol circuit32, positions a selectedmedication vial40 in a position proximate to the spikingunit42, and spikes themedication vial40 onto the spikingunit42 so that the contents of themedication vial40 enter into the mixingchamber44.
The spikingunit42 and mixingchamber44 allow for the introduction of a medication, from one of themedication vials40, into a fluid stream for intravenous delivery to a patient. The multiplemedication IV pump10 has afirst pump46, located within thehousing14, that delivers a fluid, such as a normal saline solution, from anIV bag50 or a similar source into the mixingchamber44, via a length ofIV tubing52. Asecond pump48, also located within thehousing14, pumps the fluid and a medication from the mixingchamber44 through theIV line12 to the patient. Each of thepumps46,48 is in electrical communication with, and is controlled by, thecontrol circuit32. Referring toFIG. 3, thepumps46,48 are shown alternatively mounted along with the spikingunit42 and mixingchamber44, on aninner surface29 of the cylindricalouter wall28. Thepumps46,48 and the spikingunit42 and mixingchamber44 may be collected on a removable portion of the cylindricalouter wall28, such as a hinged front panel portion, to allow for periodic removal and replacement of these components.
Returning toFIG. 2, thecarousel assembly38 of the illustrated embodiment comprises a rotatingcentral hub54 and a plurality ofarm assemblies56 extending radially from thehub54. Ahub motor58 functions to rotate thecentral hub54, under the control of thecontrol circuit32. Thehub motor58 may be engaged with thehub54 in a direct-drive configuration, or by a drive train such as thebelt drive60 shown. Thehub motor58 may be a stepping motor or another type of motor adapted for accurate positional control, such that thehub54 may be rotated into a precise position to bring anarm assembly56 into alignment with the spikingunit42. Alternatively, positional control of thehub54 may be achieved by use of appropriate positional markers and sensors on or adjacent to thehub54, the positional markers and sensors in communication with thecontrol circuit32.
Turning now toFIGS. 4,5A,5B,6A, and6B, each of thearm assemblies56 comprises amedication vial track62, having atrack support member64 and amovable track66 surrounding thetrack support member64. Thetrack support member64 is an elongated, oval arm having anouter perimeter68. Themovable track66 is entrained about theouter perimeter68 such that themovable track66 is movable along theouter perimeter68.
A plurality ofvial holders70 are disposed along themovable track66, eachvial holder70 being adapted to retain amedication vial40. Atrack motor72 is engaged to themovable track66 to move themovable track66 about thetrack support member64. Thetrack motor72 may be a stepping motor or another type of motor adapted for accurate positional control, such that themovable track66 may be positioned to bring avial holder70 into alignment with the spikingunit42. Alternatively, positional control of themovable track66 may be achieved by use of appropriate positional markers and sensors on or adjacent to themovable track66 or thetrack support member64, the positional markers and sensors in communication with thecontrol circuit32.
In conjunction with themedication vial track62, each of thearm assemblies56 comprises a vial-handlingarm74. The vial-handlingarm74 comprises a fixedmember130, the fixedmember130 being generally a hollow tubular member. Atelescoping member132 slidably extends from the fixedmember130. Afirst actuator134, such as a solenoid, is disposed within the fixedmember130 and connected to thetelescoping member132 such that thetelescoping member132 may be extended and retracted by thefirst actuator134.
A vertically pivotingmember136 is pivotally attached to thetelescoping member132. Asecond actuator138, such as a solenoid, is employed to move the vertically pivotingmember136 upward and downward. Thesecond actuator138 is disposed on the vertically pivotingmember136, and is connected to alever arm140 disposed on thetelescoping member132.
Avial grasping mechanism76 is disposed on the vertically pivotingmember136, positioned to grasp amedication vial40 from themedication vial track62 in alignment with the spikingunit42. Athird actuator142 is disposed on the vertically pivotingmember136, and is in connection with thevial grasping mechanism76 to move thevial grasping mechanism76 between an open and a closed position.
Thesecond actuator138 moves the vertically pivotingmember136 vertically such that a graspedmedication vial40 may be removed from themedication vial track62 and spiked onto the spikingunit42, and such that amedication vial40 may be lifted from the spikingunit42 for disposal, thevial grasping mechanism76 dropping themedication vial40 into thedisposal chute31. Abarcode reader78 is disposed on the vertically pivotingmember136 and oriented to read a barcode label on amedication vial40 before removal of themedication vial40 from themedication vial track62.
Turning now toFIG. 7, the spikingunit42 and mixingchamber44 are illustrated in greater detail. The mixingchamber44 comprises an enclosed receptacle having ahollow interior80. The spikingunit42 is essentially a hollow spike, or needle, extending from the mixingchamber44, and in fluid communication with thehollow interior80 of the mixingchamber44. The spikingunit42 is adapted for insertion into amedication vial40 such that the contents of the medication vial flow into thehollow interior80 of the mixingchamber44. Anaperture82 formed along the length of the spiking unit allows entry of air into aspiked medication vial40 to facilitate emptying of the contents of themedication vial40 into the mixingchamber44.
Afluid entry port84 is located near the top of the mixingchamber44. Thefluid entry port84 is connected, by afluid conduit86, to thefirst pump46 so that a fluid may be pumped by thefirst pump46 into the mixingchamber44. In use, a fluid source, such asIV bag50, is connected to thefirst pump46 to supply fluid to the mixingchamber44. Afluid exit port88 is located near the bottom of the mixingchamber44. Thefluid exit port88 is connected by afluid conduit90 to asecond pump48 so that a fluid may be pumped out from the mixingchamber44. In use, thesecond pump48 is connected toIV line12 for delivery of the fluid and a medication to a patient P.
Thehollow interior80 of the mixingchamber44 has a sufficient volume to contain a single, typical dose of a medication prepared for delivery to the patient. It should be noted that some medications will require dilution with a saline solution before delivery to the patient. Therefore, the volume of thehollow interior80 of the mixingchamber44 should accommodate a quantity of a fully diluted medication. In the illustrated embodiment, the volume is slightly greater than twenty cubic centimeters (20 CC). The mixingchamber44 may be made of a transparent material, and may include visualvolumetric indicia92 disposed thereon for ready observation of the volume of fluid contained within the mixingchamber44.
A pair of fluid level sensors provide control signals to thecontrol circuit32. Afirst level sensor94 is located near the top of the mixingchamber44 at a predefined volumetric level, such as at a twenty cubic centimeters (20 CC) level. Thefirst level sensor94 provides a signal to thecontrol circuit32 when the fluid level within the mixingchamber44 rises above this level. Asecond level sensor96 is located near the bottom of the mixingchamber44 at a predefined volumetric level, such as at a five cubic centimeters (5 CC) level. Thesecond level sensor96 provides a signal to thecontrol circuit32 when the fluid level within the mixingchamber44 falls below this level.
Turning now toFIG. 8, thecontrol circuit32 is discussed in greater detail. Thecontrol circuit32 is, in the illustrated embodiment, a microcomputer based controller having a central processing unit (CPU)100 in communication with amemory102, thememory102 including RAM and ROM memories. TheCPU100 is also in communication with atimer103. Additionally, areader104 for aremovable storage medium106 may be provided in communication with theCPU100. Thecontrol circuit32 includescontrol interfaces108 that communicate with thedisplay34 andkeypad36 to provide a user interface for the multiplemedication IV pump10. Additionally, the control interfaces108 provide for connection to thehub motor58,arm actuators75, thevial grasping mechanism76, thebarcode reader78, the first andsecond pumps46,48, and the first andsecond level sensors94,96. The control interfaces108 provide for the operation of thefirst pump46 and thesecond pump48 at a variable speed such that the fluid volume and rates of thepumps46,48 may be controlled by thecontrol circuit32. A computer program stored in thememory102 and executed by theCPU100 operates the multiplemedication IV pump10. Abattery109 may be provided to power thecontrol circuit32.
A storedmedication library110 is stored within thememory102. Referring toFIG. 9, the storedmedication library110 is a database of the types of medications that will be used with the multiplemedication IV pump10. The storedmedication library110 includes anentry112 for each of the medications that will be used with the multiplemedication IV pump10, eachentry102 including at least thename114 of the medication, thedosage116, adilution factor118 if the medication is to be diluted for use, and arepeat interval120 if the medication is to be administered repeatedly. The storedmedication library110 may be stored in the ROM portion of thememory102, or may be stored on aremovable storage medium106, the removable storage medium adapted for use with thereader104, and loaded into the RAM portion of thememory102. In addition to individual medication entries, the storedmedication library110 may include entries that indicate a medication protocol or series, wherein a medication protocol or series is simply a series of medications to be administered in a predetermined sequence and at predetermined dosages and intervals.
Turning now toFIG. 10, a typical operating sequence of the multiplemedication IV pump10 is described. Thecontrol circuit32 displays a menu of selections on the display34 (step902). A user enters a selected operation using thekeypad36. Before operation of the multiplemedication IV pump10 to deliver a fluid or medication to a patient, the multiplemedication IV pump10 must be primed.
The priming steps (not shown) include attaching anIV bag50 or other fluid source to thefirst pump46, attaching anIV line12 to thesecond pump48, and operating the multiplemedication IV pump10 in a priming mode to ensure that the fluid from theIV bag50 displaces all of the air in the system and the attachedIV line12. During the priming process, the fluid is pumped by thefirst pump46 into the mixingchamber44. Once the fluid level within the mixingchamber44 reaches thesecond level sensor96, thesecond pump48 is activated to pump the fluid through theIV line12. Once the fluid reaches the end of the IV line12 (or after a sufficient time interval for the fluid to reach end of the IV line12), bothpumps46,48 are turned off, leaving the multiplemedication IV pump10 primed with a small amount of the fluid remaining in the mixingchamber44.
With the multiplemedication IV pump10 primed, the user selects the desired mode of operation. Initially, the user selects between a bolus mode and a drip mode (at904). In the drip mode, used for ordinary infusion of IV fluids, the user enters a volume and rate for the infusion (step906), and then the multiplemedication IV pump10 begins delivery of the IV drip by operating thefirst pump46 and thesecond pump48 together, controlling the speed of thepumps46,48 to achieve the desired infusion rate (step908). To deliver a medication bolus, the bolus mode is selected. A menu of available medications is displayed on thedisplay34, displaying the medications defined in the storedmedication library110. The user selects the desired medication (or a medication protocol) using the keypad (step910). Note that a single medication may be selected, or a series or protocol of medications may be selected. In either case, the medication may be delivered according to default values contained within the storedmedication library110, or according to customized instructions that are entered when the medication or protocol is selected.
Once a medication has been selected, the medication name and information from the stored medication library is displayed on thedisplay34, along with information about the medication obtained from the storedmedication library110. If the medication is to be given repeatedly, an indication is displayed to remind the user. The medication may be repeated manually, at the initiation of the user, or automatically, at the initiation of the control circuit, according to therepeat interval120 specified in the medication'sentry112 within the storedmedication library110.
Once a medication selection has been made, thecarousel38 is activated to position amedication vial40 containing the desired medication in position at the spiking unit42 (step912). It can be noted at this point that themedication vials40 can be placed into the carousel at predetermined and predefined positions so that a given medication is selected by the position of thecarousel38. Alternatively, although potentially slower, themedication vials40 might be placed randomly within thecarousel38 and identified by thebarcode reader78 for use, themedication vials40 being retrieved one at a time until thecorrect medication vial40 is found. As an improvement to the random placement, the vials might be randomly placed, with the control circuit then performing a “learning” cycle wherein each of themedication vials40 is scanned by the barcode reader for identification, and it's position then recorded.
Assuming that themedication vials40 are stored in known positions, thecontrol circuit32 activates thehub motor58 to rotate thecarousel38 so that anarm assembly56 carrying the amedication vial40 containing the desired medication is aligned with the spikingunit42. Thecontrol circuit32 then activates thetrack motor72 of thearm assembly56 to position amedication vial40 containing the desired medication in alignment with the spikingunit42.
Thebarcode reader78 is then activated to read a barcode label on themedication vial40 aligned over the spiking unit42 (step914). If the barcode label does not match the selected medication (at916), an alarm is activated to bring attention to the error condition (step918). If themedication vial40 is correct, thevial handling arm74 is activated to grasp themedication vial40 and to spike themedication vial40 onto the spiking unit42 (step920), releasing the contents of themedication vial40 into the mixingchamber44.
Some medications are to be delivered to the patient undiluted, while others must be diluted with saline solution (or another fluid) before delivery to the patient. The medication'sentry112 in the storedmedication library110 indicates whether or not the medication is to be diluted, as reflected by thedilution factor118. If the medication is to be diluted (at922), the first andsecond pumps46,48 are operated in sequence to dilute the medication within the mixing chamber before delivery to the patient (step924). The medication is diluted by operating thefirst pump46, with thesecond pump48 off, to pump fluid into the mixingchamber44. The first pump is operated by thecontrol circuit32 at a predetermined rate, and for a fixed time interval (measured by the timer103), to pump an amount of fluid into the mixingchamber44 to dilute the medication according to thedilution factor118. Once the time interval has elapsed, and the correct amount of fluid is pumped into the mixingchamber44, thesecond pump48 is activated to deliver the diluted medication to the patient P, with bothpumps46,48 operating as the medication is delivered (step926).
If the medication is to be administered undiluted, thesecond pump48 is activated simultaneously with thefirst pump46, such that the undiluted medication is pumped to the patient P with bothpumps46,48 operating as the medication is delivered (step926). The first andsecond pumps46,48 continue operation for a sufficient time interval that a fluid flush follows the medication, to ensure that the entire dose of medication is delivered to the patient (step928).
Once the delivery of the medication is completed, thevial handling arm74 is activated to remove themedication vial40 from the spikingunit42 and to deposit themedication vial44 into the disposal chute31 (step930).
A user programmed medication sequence, or a medication protocol contained within the stored medication library, or a particular medication dosage may require that the process be repeated with the same, or with a different, medication. If the cycle is to be repeated (at932), thecontrol circuit32 repeats its operations fromstep912, activating thecarousel38 to identify and load thenext medication vial40. Otherwise, the process is complete, returning to an initial menu display to await further user operations.
In the embodiment described above, the first and second pumps are described as being contained within the housing of the multiple medication IV pump. In another embodiment, one or both of first and second pumps may be external to the housing. The components of the pumps that come into contact with the medication of the fluids being pumped are selected so that they are chemically inert with respect to the medications being administered by the multiple medication IV pump. The pumps may be peristaltic pumps designed so that the pumped fluids come into contact only with tubing of the same type used for the IV lines.
It is to be understood that the present invention is not limited to the embodiment described above, but encompasses any and all embodiments within the scope of the following claims.